Biology of Young Lung Cancer Study: The YOUNG LUNG Study

Обзор

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Подробное описание

This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:

* Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease * Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger * Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients * Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger

Study procedures will include:

* Collecting information from participants' medical record and two (2) short questionnaires * Collecting blood and/or saliva samples * Collecting tumor tissue samples (optional)

It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

Вмешательства

• Генная терапия Data and Specimen Collection
  * Provide research team access to relevant medical records * Answer two (2) short questionnaires at time of consent * Provide up to 5 tubes (37 ml) of blood at or near the time of consent, and/or saliva sample * Consider consenting to other optional parts of the research such as: * Providing additional blood or tissue samples in the future (optional) * Providing permission for obtainment of stored tissue specimens from lung cancer surgeries or biopsies from the pathology departments where t

Первичные конечные точки

• Repository of specimens and data [Срок оценки: 5 years or study closure]

Вторичные конечные точки (3)

• Number of patients with targetable somatic alterations in known oncogenic driver genes [Срок оценки: 5 years or study closure]
• Number of patients with predicted oncogenic alterations in unknown driver genes [Срок оценки: 5 years or study closure]
• Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes [Срок оценки: 5 years or study closure]

Критерии участия

Критерии включения

• Age 45 and under at lung cancer diagnosis
• Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
• Provision of written informed consent
• Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
• Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

Критерии исключения

• Individuals who decline to sign consent
• Individuals who are unable to give consent or assent and are without a designated healthcare proxy
• Compromise of patient diagnosis or staging if tissue is used for research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• Massachusetts General Hospital — Boston
• Beth Israel Deaconess Medical Center — Boston
• Brigham and Women's Hospital — Boston
• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT05265429 · 21-442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗